Clinical Data Manager

Cameron Craig Group

(Princeton, New Jersey)
Full Time
Job Posting Details
About Cameron Craig Group
The Cameron Craig Group is an executive search firm representing job openings in virtually every industry and job function across the country. We combine the efforts of over 1200 recruiters throughout the US. Together, we represent thousands of job openings and enter dozens of new jobs per day.
Summary
Our client, a well established international contract research organization serving both commercial as well as government markets, is conducting a search for a full time Direct Hire Clinical Data Manager to be based at the company's headquarters in Princeton NJ. This position provides the flexibility to work from home one or two days per week. The successful candidate will possess a forward-thinking approach and be able to anticipate challenges and proactively implement solutions.
Responsibilities
* Act as lead data manager on multiple studies of moderate complexity with minimal supervision * Main point of client contact for all DM related matters * Execute all DM start-up activities, including the development and maintenance of * CRFs/eCRFs * Edit check and custom listing specifications * Data Management Plan * CRF Completion Guidelines * Conduct user acceptance testing of data outputs per DM specifications * Organize and actively participate in CRF review meetings with the client * Perform comprehensive hands-on data review of all patient data through query management and/or manual review * Analyzes study metrics to continually assess both data quality and study progress * Track and provide project status updates to project managers for monthly project team meetings * Coordinate with Quality Assurance team to resolve any QA data issues * May assist in the mentoring of less experienced employees * Manage and prioritize project deliverables per study timelines * Reconcile SAEs and work with drug safety * Ensure that data quality and integrity is maintained from study start through database lock * Work closely with CRA's to address any negative data trends/issues specifically ahead of site visits * Provide ad hoc trainings to site members as needed * May assist the senior data manager based on study demands
Ideal Candidate
* Bachelor's degree, preferably in a science related field * 3+ years clinical data management experience in the CRO and/or pharmaceutical industry * Prior EDC experience along with demonstrated experience starting up trials (designing CRFs/eCRFs, edit checks, CRF completion guidelines, DMP, etc.). * Knowledge of GCP and ICH guidelines * A team player with strong analytical skills who is highly organized and results-oriented. * Strong attention to detail along with exceptional communication skills. * Flexibility and agility to adapt to changing scope of work

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